Meropenem aptapharma

Patient Information Leaflet

Meropenem AptaPharma, 500 mg, powder for solution for injection/infusion
Meropenem AptaPharma, 1000 mg, powder for solution for injection/infusion
Meropenemum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Meropenem AptaPharma is and what it is used for
2. Important information before using Meropenem AptaPharma
3. How to use Meropenem AptaPharma
4. Possible side effects
5. How to store Meropenem AptaPharma
6. Contents of the pack and other information

1. What Meropenem AptaPharma is and what it is used for

Meropenem AptaPharma contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that may cause serious infections.
Meropenem AptaPharma is used to treat the following infections in adults and children aged 3 months and older:

• Lung infection (pneumonia);
• Bronchitis and pneumonia in cystic fibrosis;
• Complicated urinary tract infections;
• Complicated intra-abdominal infections;
• Puerperal and postpartum infections;
• Complicated skin and soft tissue infections;
• Acute bacterial meningitis.

Meropenem AptaPharma may be used to treat febrile neutropenic patients in whom a bacterial infection is suspected.
Meropenem AptaPharma may also be used to treat bacterial blood infections that may be associated with the infections listed above.

2. Important information before using Meropenem AptaPharma

When not to use Meropenem AptaPharma

• if the patient has a known allergy to meropenem or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an allergic reaction to other antibiotics such as penicillins, cephalosporins or carbapenems, because such a patient may also be allergic to meropenem.

Warnings and precautions
Before using Meropenem AptaPharma, inform the doctor, pharmacist or nurse:

• if the patient has any health problems such as liver or kidney disease;
• if the patient has previously experienced severe diarrhoea after taking other antibiotics.

Liver-related disorders
If the patient develops yellowing of the skin or whites of the eyes, itching of the skin, dark urine or pale stools, inform the doctor. These may be symptoms of liver dysfunction, which the doctor should investigate.
During treatment, the patient may have a positive result in a certain test (the so-called Coombs test), indicating the presence of antibodies that may destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience signs and symptoms of severe skin reactions (see section 4).
If such symptoms occur, the patient should contact the doctor or nurse immediately so that appropriate treatment can be initiated.
If the patient is unsure whether any of the above conditions apply, this should be discussed with the doctor before taking Meropenem AptaPharma.

Children
Meropenem AptaPharma is not recommended for use in children under 3 months of age, as the safety and efficacy of meropenem have not been established in children under 3 months of age.

Meropenem AptaPharma and other medicines
Tell the doctor, pharmacist or nurse about all medicines currently taken, recently taken, or planned to be taken. Meropenem AptaPharma may alter the effect of certain medicines, and other medicines may affect the action of Meropenem AptaPharma.
In particular, inform the doctor or nurse if the patient is taking:

• probenecid (used in the treatment of gout);
• valproic acid, sodium valproate or valpromide (used in the treatment of epilepsy). Meropenem AptaPharma should not be used, as it may reduce the effectiveness of sodium valproate;
• oral anticoagulants (used to treat or prevent blood clots in blood vessels).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
It is recommended to avoid administering meropenem during pregnancy.
The decision on whether the patient should receive meropenem will be made by the doctor.
If the patient is breastfeeding or intends to breastfeed, it is very important to inform the doctor before receiving meropenem. Small amounts of this medicine pass into breast milk.
Therefore, the decision on using meropenem during breastfeeding will be made by the doctor.

Driving and operating machinery
No studies on the effect on the ability to drive or operate machinery have been conducted.
Treatment with meropenem has been associated with headache, prickling or tingling sensations (paraesthesiae); any of these adverse effects may affect the ability to drive or operate machinery. Meropenem may also cause involuntary muscle movements leading to rapid, uncontrolled whole-body shaking (seizures). This is usually accompanied by loss of consciousness.
If the patient experiences this adverse effect, he or she should not drive or operate machinery.

Meropenem AptaPharma contains sodium
Meropenem AptaPharma 500 mg: this medicine contains 45 mg of sodium (the main component of table salt) per vial. This corresponds to 2.3% of the recommended maximum daily sodium intake in the diet of adults.
Meropenem AptaPharma 1000 mg: this medicine contains 90 mg of sodium (the main component of table salt) per vial. This corresponds to 4.5% of the recommended maximum daily sodium intake in the diet of adults.
If the patient's health condition requires monitoring of sodium intake, this should be discussed with the doctor, pharmacist or nurse.

3. How to use Meropenem AptaPharma

This medicine should always be used exactly as instructed by your doctor or nurse. If you are unsure,
discuss it with your doctor or nurse.
Use in adults

• The dose of this medicine depends on the type of infection the patient has, the location of the infection in the body, and the severity of the infection. Your doctor will decide the dose required for you.
• The usual dose for adults ranges from 500 mg (milligrams) to 2 g (grams). The medicine is usually administered every 8 hours. However, if kidney function is impaired, doses may be given less frequently.

Use in children and adolescents

• The dose of medicine for children from over 3 months to 12 years of age depends on the child's age and body weight. The usual dose is between 10 mg and 40 mg of Meropenem AptaPharma per kilogram (kg) of body weight. The medicine is usually given every 8 hours. Children weighing over 50 kg should receive the adult dose.

How to use Meropenem AptaPharma

• Meropenem AptaPharma will be administered to you as an injection or infusion into a large vein.
• Meropenem AptaPharma will be given by a doctor or nurse.
• However, in some cases, certain patients, parents, or caregivers may be trained to administer Meropenem AptaPharma at home. Instructions for self-administration are provided in this leaflet (in section "Instructions for self-administration of Meropenem AptaPharma at home"). Always use Meropenem AptaPharma strictly according to your doctor's instructions. If you have any doubts, consult your doctor.
• The injection solution must not be mixed or added to solutions containing other medicines.
• Administration may last 5 minutes or between 15 and 30 minutes. Your doctor will decide how long the administration should last for you.
• The medicine should usually be given at the same times each day.

Accidental overdose of Meropenem AptaPharma
If you accidentally receive more medicine than prescribed by your doctor, contact your doctor immediately
or go to the nearest hospital.
Missed dose of Meropenem AptaPharma
If you miss a dose, administer it as soon as possible. However, if it is almost time for the next dose,
skip the missed dose.
Do not administer a double dose to make up for a missed dose.
Stopping Meropenem AptaPharma treatment
Do not stop using Meropenem AptaPharma unless instructed by your doctor.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Severe allergic reactions
If any of the following signs or symptoms occur, seek immediate medical advice from a doctor or nurse. The patient may require urgent medical assistance.
Signs and symptoms may include rapidly developing:

• severe rash, itching or hives on the skin;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or difficulty breathing;
• severe skin reactions including:
  • serious hypersensitivity reactions such as fever, skin rash, changes in blood test results indicating liver function abnormalities (increased liver enzyme activity), and increased number of a certain type of white blood cells (eosinophils), as well as swollen lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as drug reaction with eosinophilia and systemic symptoms (DRESS);
  • severe, red, peeling rash, skin lesions containing pus, blisters or skin peeling, which may be associated with fever and joint pain;
  • severe skin rashes that may appear as red, round spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or in a more severe form (toxic epidermal necrolysis).

Sudden chest pain, which may be a symptom of a potentially serious allergic reaction called
Kounis syndrome, has been observed during the use of other medicines of the same class. In such
a case, contact a doctor or nurse immediately.

Damage to red blood cells (haemolytic anaemia) (uncommon (may occur in up to 1 in 100 people))
Symptoms include:

• sudden onset of breathlessness;
• red or brown discoloration of urine.

If any of the above symptoms occur, seek immediate medical advice from a doctor.

Other possible adverse reactions

Common (may occur in up to 1 in 10 people)

• abdominal pain
• nausea
• vomiting
• diarrhoea
• headache
• rash, itching of the skin
• inflammation and pain
• increased platelet count (in blood tests)
• changes in diagnostic test results indicating liver function abnormalities

Uncommon (may occur in up to 1 in 100 people)

• blood abnormalities, including decreased platelet count (may cause easy bruising), increased number of certain white blood cells, decreased number of other white blood cells, increased blood bilirubin levels. The doctor may recommend regular blood tests.
• changes in blood test results, including those indicating kidney function abnormalities
• tingling sensation
• fungal infections of the mouth or vagina (thrush)
• inflammation of the intestine with diarrhoea
• pain in the veins at the site of administration of Meropenem AptaPharma
• other blood abnormalities. Symptoms include frequent infections, fever and sore throat. From time to time, the doctor may recommend regular blood tests.
• sudden onset of severe rash or formation of blisters or skin peeling. May occur with fever and joint pain.
• low potassium levels in the blood (which may cause weakness, muscle cramps, tingling and heart rhythm disturbances).
• liver-related disorders. Yellowing of the skin and whites of the eyes, itching of the skin, dark urine or pale stools. If the patient experiences these symptoms, contact a doctor immediately.

Rare (may occur in up to 1 in 1000 people)

• seizures
• acute disorientation and confusion (delirium).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Meropenem AptaPharma

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and the outer carton after "EXP". The expiry date refers to the last day of the stated month.
Store below 30°C.

Injection
After reconstitution: the intravenous injection solution should be administered immediately after preparation.
The prepared solution should not be stored for longer than:

• 3 hours at a temperature not exceeding 25°C;
• 12 hours under refrigerated conditions (2–8°C).

Infusion
After reconstitution: the intravenous infusion solution should be administered immediately after preparation.
The prepared solution should not be stored for longer than:

• 6 hours at a temperature not exceeding 25°C, if meropenem has been dissolved in sodium chloride 9 mg/mL (0.9%) solution for infusion;
• 24 hours under refrigerated conditions (2–8°C), if meropenem has been dissolved in sodium chloride 9 mg/mL (0.9%) solution for infusion;
• if meropenem has been dissolved in glucose 50 mg/mL (5%) solution for infusion, the prepared solution must be used immediately.

From a microbiological standpoint, the solution should be used immediately unless the method of opening, reconstitution, and dilution excludes the risk of microbiological contamination.
If the solution is not used immediately, the responsibility for storage duration and conditions lies with the user.
Do not freeze the reconstituted solution.
Do not use this medicine if particulate matter is observed or if there is a change in colour. Only use solutions that are colourless to yellow and free from visible particulate matter.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Meropenem AptaPharma contains
The active substance is meropenem.
Meropenem AptaPharma 500 mg:
Each vial contains meropenem trihydrate equivalent to 500 mg of meropenem.
Meropenem AptaPharma 1000 mg:
Each vial contains meropenem trihydrate equivalent to 1000 mg of meropenem.
The other ingredient is sodium carbonate.

What Meropenem AptaPharma looks like and contents of the pack
Meropenem AptaPharma is a white to pale yellow crystalline powder for solution for injection/infusion, in glass vials.
After reconstitution, the product is a clear, colourless to yellow solution.
Meropenem AptaPharma 500 mg: 20 mL vial made of colourless glass type III, with a 20 mm bromobutyl rubber stopper, a purple aluminium cap and a PP flip-off seal, packed in a cardboard box.
Meropenem AptaPharma 1000 mg: 20 mL vial made of colourless glass type III, with a 20 mm bromobutyl rubber stopper, a grey aluminium cap and a PP flip-off seal, packed in a cardboard box.
The pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer/Importer
ACS Dobfar S.p.A.
Nucleo Industriale S. Atto, S. Nicolò a Tordino
64100 Teramo
Italy

This medicinal product is authorised in the European Economic Area member states under the following names:

Medical advice / information
Antibiotics are used to treat bacterial infections. They are ineffective
against viral infections.
There are cases of bacterial infections that do not respond to antibiotic treatment. One
of the most common reasons for such cases is bacterial resistance to the antibiotic used.
This means that despite the use of an antibiotic, some bacteria may survive or multiply.
There are many causes of bacterial resistance. Proper use of antibiotics can reduce
the likelihood of bacteria developing resistance, which renders the antibiotic ineffective.
When a doctor prescribes an antibiotic, it is intended to treat only the illness currently affecting
the patient. By following the advice below, you can help prevent bacterial resistance, which causes antibiotics to stop working.

1. It is very important to take the antibiotic at the correct dose, at the correct times, and for the correct number of days. Read the instructions in the patient leaflet, and if in doubt, consult your doctor or pharmacist for clarification.
2. Do not use an antibiotic unless it has been prescribed for you by a doctor, and use it only to treat the infection for which it was prescribed.
3. Do not use an antibiotic prescribed for another person, even if their symptoms are similar.
4. Do not give away an antibiotic prescribed for you to other people.
5. Any unused leftover antibiotic prescribed for you should be returned to a pharmacy for proper disposal.

The following information is intended exclusively for medical personnel or healthcare professionals
To obtain complete information on dosing, warnings, and precautions, please refer to the Product Characteristics.
Instructions for self-administration of Meropenem AptaPharma at home
Some patients, parents, and caregivers may be trained to administer Meropenem AptaPharma at home.
Warning. The medicine may be self-administered at home only after prior training by a doctor or nurse.
How to prepare the medicine

• This medicine must be mixed with another liquid (diluent). Your doctor will instruct you on how much diluent to use.
• The medicine should be administered immediately after preparation. Do not freeze the prepared medicine.
  1. Wash and thoroughly dry your hands. Prepare a clean work area.
  2. Remove the vial of Meropenem AptaPharma from its packaging. Check the vial and the expiration date. Check for any signs of damage to the medicine's packaging.
  3. Remove the coloured cap and wipe the grey rubber stopper with an alcohol-impregnated swab. Wait for the stopper to dry.
  4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the tips.
  5. Draw into the syringe the recommended amount of water for injections. The required amount of water is given in the table below:

6. Pierce the grey rubber stopper with the syringe needle and inject the water for injection from the syringe into the vial or vials of Meropenem AptaPharma.
7. Remove the needle from the vial and shake the vial well for about 5 seconds or until the powder is completely dissolved. Wipe the rubber stopper again with a new alcohol-impregnated swab and wait for the stopper to dry.
8. Ensure the syringe plunger is fully depressed, then reinsert the needle through the grey rubber stopper. Hold both the syringe and the vial, and invert the vial upside down.
9. Keeping the tip of the needle submerged in the solution, pull back on the syringe plunger to draw the solution from the vial into the syringe.
10. Disconnect the syringe with the needle from the vial and set the empty vial aside in a safe place.
11. Hold the syringe vertically with the needle tip pointing upwards. Gently tap the syringe so that air bubbles rise to the upper part of the syringe.
12. Remove all air from the syringe by gently pressing the plunger until all gas has escaped.
13. If Meropenem AptaPharma is being used at home, used needles and infusion lines must be disposed of properly. If the physician decides to discontinue treatment, unused medication should be discarded according to local regulations.

Administration of the Medicinal Product
The medicinal product may be administered via a short cannula or venflon, or through a port or central line.
Administration of Meropenem AptaPharma via a short cannula or venflon

1. Remove the needle from the syringe and carefully dispose of it in a container designated for sharp waste.
2. Clean the end of the cannula or venflon with an alcohol-impregnated swab and wait for it to dry. Remove the cannula cap and attach the syringe.
3. Slowly depress the syringe plunger to administer the antibiotic evenly over approximately 5 minutes.
4. After completion of antibiotic administration and emptying of the syringe, disconnect the syringe and flush the cannula according to the physician's or nurse's instructions.
5. Cap the cannula and carefully dispose of the syringe in a container designated for sharp waste.

Administration of Meropenem AptaPharma via a port or central line

1. Remove the cap from the port or central line, clean the end of the line with an alcohol-impregnated swab, and wait for it to dry.
2. Attach the syringe and slowly depress the plunger to administer the antibiotic evenly over approximately 5 minutes.
3. After completion of antibiotic administration, disconnect the syringe and flush the line according to the physician's or nurse's instructions.
4. Attach a new cap to the central line and carefully dispose of the syringe in a container designated for sharp waste.